Phase 1/2 CTO + Bevacizumab for Recurrent Glioma Post-Bevacizumab Failure

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Annick Desjardins
Study ID
NCT01954030
Phase
PHASE1
Status
Terminated

Conditions

  • Malignant Glioma (WHO Grade III or IV)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objectives of the study are to determine the maximum tolerated dose (MTD) of Carboxyamidotriazole Orotate (CTO) when combined with standard dosing of bevacizumab among patients with recurrent malignant glioma (WHO grade III or IV) that have previously failed bevacizumab (Phase 1); to determine the activity of CTO alone in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 1); to determine the activity of CTO plus bevacizumab in bevacizumab-failure WHO grade IV malignant glioma patients (Phase 2, Arm 2). This study was terminated early due to funding issues. At the time of termination, the study was still in Phase 1 and no MTD for the combination of CTO and bevacizumab had been determined for this population. Phase 2 will not proceed.

Key Dates

First listed
Oct 1, 2013
Start date
Oct 31, 2013
Status verified
Feb 2016
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CTO and Bevacizumab (Phase 1)
    The combination of CTO with the standard dosing of bevacizumab of 10 mg/kg every 2 weeks among patients with recurrent malignant glioma (World Health Organization (WHO) grade III or IV) that have previously failed bevacizumab
  • Experimental: Phase 2: CTO alone (Phase 2)
    The first 25 patients will be treated with CTO alone at the maximum tolerated dose (MTD) established in the Phase 1 portion of the study.
  • Experimental: CTO and Bevacizumab (Phase 2)
    The second group of 25 patients will be treated with the combination of CTO at the MTD established in the Phase 1 portion of this study and standard dosing of bevacizumab.

Primary Outcome Measure

Phase 1: Determine the Maximum Tolerated Dose (MTD) of CTO when combined with standard dosing of bevacizumab [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Preston Robert Tisch Brain Tumor Center at DukeDurhamNorth Carolina27710-

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By research site
The Preston Robert Tisch Brain Tumor Center at Duke· Durham, NC

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